Head of Regulatory Affairs, Cell Therapy Immunology
Head of Regulatory Affairs, Cell Therapy Immunology
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$ 266596 - 399895
1 Vacancy
Job Description
Join us at AstraZeneca where we are using cell therapy to redefine the treatment of lifethreatening immunemediated diseases. Our exceptional team is working on the ground breaking area of cellular therapies and we are investing in internal capabilities to discover and accelerate the delivery of nextgeneration cellular therapies for patients. As part of our Regulatory Affairs team you will play a crucial role in bringing these transformative therapies from the lab to life.
The Head of Regulatory Affairs Immunology Cell Therapy should be comfortable interacting with senior leaders a tough negotiator can make decisions in ambiguity decisive leader and a realist while providing global strategic regulatory expertise and oversight to support products through research development and commercialisation. Their expertise applies to early late and postmarketing development stages for cell therapy products being developed for immunemediated diseases. The role will quickly navigate new environments or tackle opportunities while developing a growing organization. They ensure that adequate regulatory resource and skills are provided in line with designated disease area strategies and portfolio to enhance the likelihood of success which meet business needs health authorities and patients. They will partner with functions to ensure regulatory experts are assigned to provide strategic regulatory and development advice/direction at the time of key milestone investment decisions across the portfolio.
How you will make a difference:
Provide oversight partner with and mentor RADs and SrRADs to produce strategies for a product/group of products in the Immunology Cell Therapy TA that are consistent with the disease area and portfolio strategy. The strategies should be crafted and negotiated with global health authorities (e.g FDA EMA CDE) to deliver a rapid approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business and patients.
Leads discussions in both internal and external forums providing expertise in regulatory knowledge of disease area.
Influences and drives regulatory strategies and recommendations at all stages of development in early and late development and for established brands on regulatory components of development specific to cell and gene therapies as well as other tools such as novel endpoints/biomarkers novel study designs and digital applications.
Effectively represent the Regulatory function in senior level interactions at internal governance technical review committees e.g. Development Review Committee (DRC/eDRC) Early Development Review Board Global Medical Affairs (GMA) Review Committees
Works in collaboration with regional policy and intelligence groups to critically analyse the assessment of emerging science data and changes in the regulatory environment
Defines and drives disease area global regulatory policies and priorities within the TA
What Youll Need:
Bachelors degree in life sciences and/or science related field and/or other appropriate knowledge/experience.
More than 10 years drug development experience
Broad experience of the therapeutic area with specific cell therapy immunology regulatory sciences expertise and immunemediated diseases.
Experience in global regulatory strategy and submissions that have progressed through to registration
Must have significant experience in leading major Health Authority interactions
Broad background of experience working in pharmaceutical/medical industry and prior experience in several areas within regulatory affairs e.g. Global European International Marketing Company or experience at a health authority.
Experience in managing people in a matrixed organizational structure
Preferred:
Advanced degree in a scientific field (e.g. MSc PhD PharmD MD)
This role must be based in our Boston office.
When we put unexpected teams in the same room we unleash bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
The annual base salary for this position in the US ranges from $266596.80 $399895.20. However base pay offered may vary depending on multiple individualized factors including market location jobrelated knowledge skills and experience. In addition our positions offer a shortterm incentive bonus opportunity; eligibility to participate in our equitybased longterm incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an atwill position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industryleading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on nondiscrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.
So whats next!
Are you already imagining yourself joining our team Good because we cant wait to hear from you.
Where can I find out more
Our Social Media Follow AstraZeneca on LinkedIn
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02May2025Closing Date
30May2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion starting with our recruitment process. We welcome and consider applications from all qualified candidates regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations please complete the section in the application form.Required Experience:
Director
Employment Type
Full-Time
Key Skills
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